WO2014126653A1 - Dispositif à fil-guide médical orientable - Google Patents

Dispositif à fil-guide médical orientable Download PDF

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Publication number
WO2014126653A1
WO2014126653A1 PCT/US2014/010219 US2014010219W WO2014126653A1 WO 2014126653 A1 WO2014126653 A1 WO 2014126653A1 US 2014010219 W US2014010219 W US 2014010219W WO 2014126653 A1 WO2014126653 A1 WO 2014126653A1
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WO
WIPO (PCT)
Prior art keywords
electrode
layer
eap
guide wire
layers
Prior art date
Application number
PCT/US2014/010219
Other languages
English (en)
Inventor
Shihai Zhang
Stephen Davis
Mark Levatich
Richard Ducharme
Original Assignee
Novasentis, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novasentis, Inc. filed Critical Novasentis, Inc.
Publication of WO2014126653A1 publication Critical patent/WO2014126653A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0158—Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0058—Catheters; Hollow probes characterised by structural features having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/0915—Guide wires having features for changing the stiffness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated

Definitions

  • FIG. 1 illustrates the use of a guide wire.
  • the guide wire 1 10 is feed into a patient along a pathway 120 such as a vascular tract or other lumen in the body.
  • a needle or knife is typically used to create an opening to the pathway in a patient if the target body lumen is not externally accessible.
  • the guide wire is then advanced through the pathway to a target location in the patient.
  • a catheter, stent or other medical device may be guided to the target location by the guide wire.
  • a catheter may be fed over the base of the guide wire and then advanced up the guide wire to the target location.
  • the guide wire improves access to treatment locations within the patient body.
  • the medical device includes a guide wire and a drive unit coupled to the guide wire.
  • the guide wire includes one or more layers of a first electrode, one or more layers of a plurality of second electrodes and one or more
  • EAP electroactive polymer
  • Each EAP layer is disposed between a layer of a first electrode and a layer of a plurality of second electrodes.
  • the drive unit is adapted to generate one or more potential voltages and to apply each of the one or more potential voltages respectively across one or more sets of the first electrode and the second electrode.
  • the one or more potential voltages can be selectively applied across the EAP layer to steer the guide wire, control the shape of the guide wire, adjust the rigidity of the guide wire, and/or cause one or more portions of the guide wire to vibrate.
  • the medical device may include a catheter or the like and a drive unit.
  • Such medical devices similarly include one or more layers of a first electrode, one or more layers of a plurality of second electrodes and one or more EAP layers
  • the guide wire, catheter or the like includes a plurality of active EAP portions arranged in multiple stacks.
  • the active EAP portions in each stack are aligned with each other and perpendicular to a longitudinal axis of the guide wire, catheter or the like.
  • the stacks are arranged along the longitudinal axis of the guide wire, catheter or the like.
  • a drive unit coupled to the guide wire, catheter, or the like generates one or more potential voltages.
  • the drive unit applies the potential voltage across one or more active EAP portions to control one or more physical parameter of the guide wire, catheter or the like.
  • the physical parameters may include the deflection, the rigidity and/or the like of the guide wire, catheter or the like.
  • Figure 1 illustrates the use of a conventional guide wire medical device.
  • Figure 2 shows a block diagram of a guide wire medical device, in accordance with one embodiment of the present technology.
  • Figure 3 shows a block diagram illustrating operation of the guide wire medical device, in accordance with one embodiment of the present technology.
  • Figure 4 shows a block diagram illustrating operation of the guide wire medical device, in accordance with another embodiment of the present technology.
  • Figure 5 shows a flow diagram of a method of using a guide wire medical device, in accordance with one embodiment of the present technology.
  • Figure 6 shows a block diagram of an exemplary guide wire medical system, in accordance with one embodiment of the present technology.
  • Figure 7 shows a block diagram of a guide wire drive unit and control system, in accordance with one embodiment of the present technology.
  • Figure 8 shows a block diagram of a guide wire medical device, in accordance with another embodiment of the present technology.
  • Figure 9 shows a flow diagram of a method of manufacturing a guide wire medical device, in accordance with one embodiment of the present technology.
  • Figure 10 shows a block diagram of a guide wire medical device, in accordance with another embodiment of the present technology.
  • Figure 1 1 shows a flow diagram of a method of manufacturing a guide wire medical device, in accordance with another embodiment of the present technology.
  • Figure 12 shows a block diagram of a guide wire medical device, in accordance with yet another embodiment of the present technology.
  • Figure 13 shows a flow diagram of a method of manufacturing a guide wire medical device, in accordance with yet another embodiment of the present technology.
  • Figure 14 shows a block diagram of a guide wire medical device, in accordance with another embodiment of the present technology.
  • Figure 15 shows a block diagram of a catheter medical device, in accordance with yet another embodiment of the present technology.
  • Figure 16 shows a block diagram of a wire guide or catheter medical device, in accordance with yet another embodiment of the present technology.
  • routines, modules, logic blocks, and other symbolic representations of operations on data within one or more electronic devices are presented in terms of routines, modules, logic blocks, and other symbolic representations of operations on data within one or more electronic devices.
  • the descriptions and representations are the means used by those skilled in the art to most effectively convey the substance of their work to others skilled in the art.
  • a routine, module, logic block and/or the like is herein, and generally, conceived to be a self-consistent sequence of processes or instructions leading to a desired result.
  • the processes are those including physical manipulations of physical quantities.
  • these physical manipulations take the form of electric or magnetic signals capable of being stored, transferred, compared and otherwise manipulated in an electronic device.
  • these signals are referred to as data, bits, values, elements, symbols, characters, terms, numbers, strings, and/or the like with reference to embodiments of the present technology.
  • the guide wire has an elongated form factor of a flexible rod, wherein the longitudinal dimension of the guide wire is substantially larger than the other dimensions, such as diameter or width, of the form factor.
  • the dimension of the guide wire form factor are adapted for use in one or more body lumens within one or more living organism.
  • the guide wire or one or more components of the guide wire may include a lumen. In other embodiments, the guide wire may not have any lumens.
  • the guide wire includes a plurality of electroactive polymer (EAP) layers 210, a plurality of first electrodes 220 and a plurality of second electrodes 230.
  • EAP electroactive polymer
  • the EPA layers and first and second electrode layers are coupled together as an EAP construct.
  • the various layers of EAP, first and second electrodes, along with optional layers such as insulator, sheath and the like layers may be coupled directly to each other or may be coupled together by an appropriate adhesive. It is to be appreciated that the illustrated guide wire is not to scale.
  • the guide wire may be approximately 2-500 centimeters (cm) in length.
  • the guide wire may be approximately 0.2-5 millimeter (mm) in diameter or width.
  • the first and second electrodes are typically 1/10-1/50 the thickness of the EAP layers.
  • the first and second electrodes may be a conductive polymer, a metal such as gold or platinum, or alloys thereof.
  • Each EAP layer is disposed between layers of a first electrode and a second electrode.
  • the use of the term "disposed between” herein is intended to include directly and indirectly between.
  • each EAP layer may be between respective layers of a first electrode and a second electrode.
  • the guide ware may include a first EAP layer between a first one of a first electrode and a first one of a second electrode, a second EAP layer may be between a second one of the first electrode and a second one of the second electrode, and so on.
  • adjacent EAP layers may share the same electrode between the two EAP layers to reduce the number of electrode layers.
  • the guide wire may include a first EAP layer between a first one of a first electrode and a first one of a second electrode as illustrated in the Side View of Figure 2.
  • a second EAP layer may be between the first one of the second electrode and a second one of the first electrode.
  • a third EAP may be between the second one of the first electrode and a second one of the second electrode.
  • one or more EAP layers may be between a first number of layers of a first electrode and a second number of layers of a second electrode.
  • a first EAP layer may be between a first one of a first electrode and a first one of second electrode.
  • a second EAP layer may be between a second one of the first electrode and the first one of the first electrode.
  • the second EAP layer in such case will also be indirectly between the second one of the first electrode and the first one of the second electrode.
  • a third EAP layer may be between a third one of the first electrode and the second one of the first electrode. Again, the third EAP layer in such case will also be indirectly between third one of the First electrode and the first one of the second electrode.
  • the plurality of EAP layers are disposed between one or more layers of a first electrode and one or more layers of a second electrode such that when a potential voltage is applied between the first electrode and second electrode an electric field is applied across the plurality of EAP layers.
  • the EAP layer may be an electrostrictive relaxor ferroelectric EAP.
  • the electrostrictive relaxor ferroelectric EAP layer may be a ter-polymer including at least one monomer of vinylidene-fluoride, at least one monomer selected from the group consisting of trifluoroethylene and tetrafluoroethylene, and at least one monomer selected from the group consisting of tetrafluoroethylene, vinyl fluoride, perfluoro (methyl vinyl ether), bromotrifluorethylene, chlorofluoroethylene, chlorotrifluoroethylene, and hexafluoropropylene.
  • the ter-polymer may be a polyvinylidene fluoride (PVDF) such as P(VDF x -TrFEy-CFEi -x-y ), P(VDF x -TrFE y - CTFEi-x- y ), poly(VDF x -TrFE y -vinylidene chloride i -x-y ), poly(vinylidene fluoride- tetrafluoroethylene-chlorotrifluoroethylene), poly(vinylidene fiuoride-trifluoroethylene- hexafluoropropylene), poly(vinylidene fluoride-tetrafluoroethylene- hexafluoropropylene), poly(vinylidene fluoride-trifluoroethylene-tetrafluoroethylene), poly(vinylidene fluoride-trifluoroethylene-tetrafluoroethylene), poly(vinylidene fluoride
  • the electrostrictive relaxor ferroelectric EAP layer may be an irradiated polyvinylidine fluoride polymer.
  • the irradiated polyvinylidine fluoride polymer may be polyvinylidine fluoride-trifluoroethylene P(VDF- TrFE), polyvinylidine fluoride tetrafluoroethylene P(VDF-TFE), polyvinylidine fluoride trifluoroethylene-hexafluoropropylene P(VDF-TFE-HFE) and polyvinylidine fluoride- hexafluoropropylene P(VDF-HFE).
  • a thickness strain (S3) of electrostrictive relaxor ferroelectric EAPs of up to 7% or more can be achieved under an applied electric field of up to approximately 140 megavolts per meter (MV/m).
  • a transverse stain (SI), with respect to the thickness dimension of electrostrictive relaxor ferroelectric EAPs, of up to 5% or more can be achieved for an applied electric field of up to approximately 140 MV/m.
  • SI transverse stain
  • electrostrictive relaxor ferroelectric EAPs exhibit an elastic modulus of approximately 100 MegaPascals (MPa) or more.
  • MPa MegaPascals
  • each layer of the first and/or second electrode may be a continuous sheet, as illustrated in Example 1 of Figure 2.
  • the EAP layer disposed between respective first and second electrode layers are active and expand when a voltage potential as applied by the first and second electrode layer across the corresponding EAP layer.
  • the layers of the first electrode and/or second electrode may be patterned into a plurality of electrodes in each layer, as illustrated in Examples 2 and 3 of Figure 2. For instance, the layer of first electrodes may be patterned into a plurality of first electrodes.
  • the first and second electrodes may be arranged in a large variety of patterns, including linear patterns, array patterns, geometrically expanding patterns, radial patterns, axial patterns, spiral patterns or other geometries which provide sufficient electric field strengths to achieve a desired electroactive response.
  • geometrically expanding pattern means a pattern that when rolled, folded or the like into a guide wire or catheter form factor, the corresponding active portions of the EAP stack on top of each other. Each stack of active EAP effectively forms a respective actuator.
  • the portions of the EAP layer disposed between respective first and second electrodes are active portions, while those portions that do not have a first and second electrode disposed directly or indirectly on either side of them are inactive.
  • One or more dimensions of the active portions will change as a function of a potential voltage applied to the first and second electrodes across the EAP.
  • the EAP layer may be an electrostrictive relaxor ferroelectric EAP.
  • the electrostrictive relaxor ferroelectric EAP may be formed from a ferroelectric polymer by introducing chloride containing monomers such as chlorofluoroethylene (CFE) and chlorotrifluoroethylene (CTFE) or hexafluoropropylene to the copolymer to introduce polarization defects that destabilize the ferroelectric phase.
  • CFE chlorofluoroethylene
  • CTFE chlorotrifluoroethylene
  • the electrostrictive relaxor ferroelectric EAP may be formed by irradiating P(VDF-TrFE) with high-energy electrons or protons to cause polarization defects.
  • the electrostrictive relaxor ferroelectric EAP material possess dipoles that may be aligned in a ferroelectric state (beta phase) when an electric field is applied.
  • the dipoles When the electric field is removed the dipoles return to a paraelectric state (alpha phase).
  • the defects reduce the size of the crystallites which lowers the energy barrier required for transitions between paraelectric and ferroelectric states.
  • the length of the crystallites increase in the ferroelectric state relative to the paraelectric state.
  • the crystallites in the electrostrictive relaxor ferroelectric EAP layer may be oriented in one direction (e.g., uniaxially). In the uniaxially oriented electrostrictive relaxor ferroelectric EAP the increase length of the crystallites cause a corresponding increase in the EAP material along the orientation direction.
  • the change in the length of the EAP layers is utilized to control the shape and/or rigidity of the guide wire.
  • the change in the shape and/or rigidity can be used to steer the guide wire along a desired pathway.
  • the change in the shape can also be used to vibrate the guide wire to aid in advancing the guide wire along the desired path.
  • the range of rigidity can be used to aid in advancing the guide wire along the desired path.
  • the guide wire may be made relatively flexible to avoid damaging tissue along the path or may be made relatively stiff to push past a particular area.
  • Electroactive polymers may also be referred to as electromechanical polymers (EMP).
  • EMP electromechanical polymers
  • the term electroactive polymer as used herein is not intended to be different from electromechanical polymers. Instead, embodiments of the present technology may utilize any electrostrictive relaxor ferroelectric or the like EAP or EMP material.
  • the guide wire may include a plurality of EAP layers, each disposed directly or indirectly between a respective set of a first and second electrode layers.
  • the first and second electrode layers may be continuous electrode sheets.
  • a potential may be applied across a first set of the plurality of EAP layers causing the first set of EAP layers to expand predominantly in a longitudinal direction.
  • the elongation of the first set of EAP layers relative to the second set of EAP layers causes the guide wire structure to bend in a plane perpendicular to the plane of the layers of the guide wire. The bending can be used to steer the guide wire and/or achieve a particular shape of the guide wire.
  • one or more active EAP sections can be placed in tension with one another to achieve a given rigidity.
  • the EAP layers may be comprised of electrostrictive relaxor ferroelectric EAP material.
  • the electrostrictive relaxor ferroelectric EAP generates a force when biased as a function of the product of the polymer's Young's modulus and the thickness of the polymer when a potential voltage is applied. Therefore, a plurality of EAP layers may be advantageously utilized to increase the force that the guide wire can generate for a given thickness of the EAP layers. Alternatively, a plurality of EAP layers may be advantageously utilizes to reduce the applied potential voltage utilized to generate a given force for a given thickness of the EAP layers.
  • the EAP layers may be 3 micro-meters ( ⁇ ) thick.
  • an electric potential of 180V e.g., 60 V/ ⁇
  • an electric potential of 300 V can be applied to the left most EAP layer while an electric potential of 120 V is applied to the right most EAP layer.
  • the lower potential voltage applied to right most EAP layer resists the bending motion of the left most EAP layer, thereby stiffening the guide wire.
  • the guide wire may have a single EAP layer.
  • a single EAP layer coupled to another layer such as a substrate layer, sheath layer, or the like may deflect as a result of the change in length of the EAP layer without a corresponding change in the other layer.
  • the guide wire may include a plurality of EAP layers, each disposed between a respective set of a first and second electrode layers.
  • Each layer of the first and/or second electrode includes a plurality of electrodes arranged in a given pattern and separated from each other by an insulator region 240.
  • Each electrode in a layer is aligned with the corresponding electrode in the other layers.
  • the portions of the EAP layers disposed between the first and second electrodes are active EAP portions and those portions of the EAP layers that are not disposed between the first and second electrode (e.g., proximate the insulator regions separating electrodes in the same layer) are inactive EAP portions.
  • the active EAP portions are aligned in stacks between the layers of the guide wire.
  • Different potential voltages can be applied to different electrodes relative to other electrodes in the same layer and/or corresponding electrodes in other layers to form a given shape of the guide wire.
  • a first potential can be applied to the left most active EAP portions in the first active EAP stack to cause a relatively small deflection of the guide wire to the right.
  • a second potential that is larger than the first potential can be applied to the two left most active EAP portion in the second active EAP stack to cause a larger deflection of the guide wire to the right.
  • a third potential can be applied to the right most active EAP in the third active EAP stack to cause the guide wire to reduce the deflection of the guide wire to the right.
  • the guide wire can advantageously be steered to different places by applying different potential voltages to different active portions of the EAP.
  • Applying different potential voltages to different active portion of the EAP can also be used to change the rigidity of the guide wire or a portion therefore.
  • the applied potential voltages can also be varied to cause the guide wire or a portion thereof to vibrate, which can facilitate advancement of the guide wire along the path.
  • the method may begin with receiving one or more control signals for controlling one or more physical parameters of the guide wire, at 510.
  • the one or more physical parameters may include the deflection of the guide wire, the rigidity of the guide wire, and/or the like.
  • one or more potential voltages are generated for controlling one or more physical parameters of the guide wire based upon the received control signals.
  • the one or more potential voltages are applied across one or more particular active EAP portions of the guide wire based upon the received control signals.
  • the potential voltages applied across one or more particular active EAP regions may be adapted to steer the guide wire as it is moved along a pathway within a patient.
  • the applied potential voltages may also be adapted to form and/or hold a particular shape in the guide wire alone or in combination with steering the guide wire.
  • the applied potential voltages may also be adapted to control the rigidity from relatively flexible to relatively rigid.
  • the applied potential voltages may also be adapted to vibrate one or more portions of the guide wire.
  • one or more parameters of the guide wire may be determined.
  • the insertion depth of the guide wire, the deflection of the guide wire, or the like is determined from one or more gauges.
  • the one or more determined parameters of the guide wire may be output, at 550.
  • the one or more determined parameter of the guide wire may be output for use in generating additional control signals for controlling the one or more physical parameter of the guide wire, presentation on a display to an operator of the guide wire, and/or the like.
  • the system includes a guide wire or catheter 610, a drive unit 620 coupled to the guide wire or catheter, and a control system 630 communicatively coupled 640 to the drive unit.
  • the control system may be communicatively coupled to the drive unit by one or more wired and/or wireless communication links.
  • the guide wire or catheter 610 may include one or more lumens 650, such as a lumen for passing a liquid for flushing the body lumen, a lumen for a camera, a lumen for a device such as an ablation tip, and/or the like.
  • a plurality of multi-layer EAP actuators 660 may be molded into a body lumen material, or the guide wire or catheter may be substantially formed by the multi-layer EAP actuators as illustrated in other embodiments herein.
  • the multi-layer EAP actuators 660 may be arranged in one or more sets.
  • the multilayer EAP actuators 660 are couple to the drive unit by respective electrical interconnects 670.
  • the drive unit 620 may include a power source 705, drive logic 710 and a transceiver 715.
  • the drive logic is coupled to the power source and the transceiver.
  • the power source may be a battery in one implementation.
  • the power source may be a rechargeable battery.
  • the battery may be wirelessly recharged from electromagnetic energy received through an optional wireless recharge receiver 720 coupled to the rechargeable battery.
  • the power source is provided by the control system or another device.
  • the control system may be a dedicated system or may a general purpose computing system, such as a personal computer (PC), workstation, or the like.
  • the control system 530 may include a processing unit 725, system memory 730, a transceiver 735, and one or more additional input/output devices 740-750 communicatively coupled together by one or more buses 755.
  • the input/output device may include a keyboard 740, a pointing device, a display 745, a hard disk drive (HDD) 750, an optical disk drive, and/or the like.
  • the system memory e.g., computing device readable media
  • instructions e.g., computing device executable instructions
  • the processing unit generates control signals for controlling one or more physical parameter of the guide wire.
  • the transceiver of the control system is adapted to send the control signals to the transceiver of the drive unit.
  • the drive logic generates one or more potential voltages from the power source in accordance with the received control signals.
  • the drive logic applies the one or more potential voltages across one or more active EAP regions based upon the received control signals.
  • the applied voltage potentials may steer the tip of the guide wire, change the shape of the guide wire, change the rigidity of the guide wire and/or cause the guide wire to vibrate.
  • the transceiver of the drive unit may also be adapted to provide control signals regarding one or more parameters of the guide wire to the guide wire control system.
  • one or more strain gauges (not shown) in the guide wire may generate location control signals that are received by the transceiver of the control system and output on a display.
  • the control signals may be generated as a function one or more predetermined software routines (e.g., preconfigured), as a function of guide wire position and pathway information from another device (e.g., automatic), as a function of operator input (e.g., manual), and/or the like.
  • the generated control signals may steer the lead section of the guide wire and control the following sections to have the deflection of the lead section when it was present at the corresponding depth.
  • the generated control signals may change the rigidity of the guide wire and/or cause the guide wire to vibrate.
  • the functions of steering, shaping, controlling the rigidity and/or vibrating the guide wire may advantageously reduce trauma to the surrounding tissue.
  • embodiments of the present technology such as the method of use described in Figure 5, the medical system described in Figure 6 and the drive unit described in Figure 7, may be applied to other medical devices such as catheters or the like percutaneous instruments.
  • the guide wire may include a core 810, one or more EAP layers 210, one or more layers of a first electrode 220 and one or more layers of a second electrode 230.
  • the one or more EAP layers are disposed between alternating ones of the first electrode and second electrode.
  • the stack of one or more EAP layers and alternating first and second electrodes may be disposed around a portion of the core or the entire length of the core.
  • the guide wire may further include one or more insulator layers 820, electrical interconnect layers, sheath layers 830, and the like.
  • the guide wire may further include additional layers for forming strain gauges, temperature sensors, heating elements, cooling elements, and/or the like.
  • the first or second electrode or a portion thereof may be the core of the guide wire.
  • the process may include forming a layer of a first electrode over a core, at 910.
  • the core may be a nitinol (e.g., alloy of nickel and titanium), plastic, or the like wire that resist kinking.
  • the first electrode may be formed directly on the core or on an optional intervening insulator layer.
  • the first electrode layer may be formed by dip or spray coating, sputtering, platting, vapor deposition or the like of a conductive material conformally onto the core.
  • the first electrode layer may be formed by sputtering gold, titanium, aluminum or the like on the core or an intervening insulator layer.
  • the core if conductive may be utilized as the first electrode.
  • an EAP layer is formed on the layer of the first electrode.
  • the EAP layer may be formed by dip or spray coating, sputtering, vapor deposition or the like of an EAP material conformally onto the first electrode layer.
  • the EAP layer is prepared and synthesized by ploymerizing processes such as suspension, emulsion or solution methods.
  • the monomers e.g., VDF, TrFE, CFE
  • the resulting polymer system should have a convenient molecular weight suitable for use in an electrical or electromechanical device.
  • the molecular weight of the polymer system is, however, not limited.
  • the molecular weight of polymer is preferably, but not limited, to higher than about 50,000, 100,000 or 300,000.
  • the EAP material may be an electrostrictive relaxor ferroelectric EAP.
  • the electrostrictive relaxor ferroelectric EAP may be formed from a ferroelectric polymer by introducing crystallinity reducing monomers such as chlorofluoroethylene (CFE) and chlorotrifluoroethylene (CTFE) or hexafluoropropylene to the copolymer.
  • the electrostrictive relaxor ferroelectric EAP material may include at least one monomer of vinylidene-fluoride, at least one monomer selected from the group consisting of trifluoroethylene and tetrafluoroethylene, and at least one monomer selected from the group consisting of tetrafluoroethylene, vinyl fluoride, perfluoro (methyl vinyl ether), bromotrifluorethylene, chlorofluoroethylene, chlorotrifluoroethylene, and
  • Exemplary ter-polymers may be a polyvinylidene fluoride (PVDF) such as P(VDF x -TrFEy-CFE, -x-y ), P(VDF x -TrFEy-CTFEi -x-y ), poly(VDFx-TrFEy-vinylidene chloride i -x-y ), poly(vinylidene fluoride-tetrafluoroethylene-chlorotrifluoroethylene), poly(vinylidene fluoride-trifluoroethylene-hexafluoropropylene), poly(vinylidene fluoride- tetrafluoroethylene- hexafluoropropylene), poly(vinylidene fluoride- tetrafluoroethylene- hexafluoropropylene), poly(vinylidene fluoride-trifluoroethylene- tetrafluoroethylene), poly(vinylidene fluoride
  • the electrostrictive relaxor ferroelectric EAP may be formed by irradiating a polyvinylidine fluoride polymer, such as polyvinylidine fluoride- trifluoroethylene P(VDF-TrFE), polyvinylidine fluoride tetrafluoroethylene P(VDF-TFE), polyvinylidine fluoride trifluoroethylene-hexafluoropropylene P(VDF-TFE-HFE) and polyvinylidine fluoride-hexafluoropropylene P(VDF-HFE) with high-energy electrons or protons.
  • a polyvinylidine fluoride polymer such as polyvinylidine fluoride- trifluoroethylene P(VDF-TrFE), polyvinylidine fluoride tetrafluoroethylene P(VDF-TFE), polyvinylidine fluoride trifluoroethylene-hexafluoropropylene P(VDF-TFE-HFE) and polyviny
  • the EAP may then be irradiated in an oxygen free atmosphere with an electron energy in the range from about 500 kilo-electron volts (KeV) to about 3 mega-electron volts (MeV) to produce the electrostrictive relaxor ferroelectric EAP
  • a layer of a second electrode is formed on the EAP layer.
  • the second electrode layer may be formed by dip or spray coating, sputtering, platting, vapor deposition or the like of a conductive material conformally onto the EAP layer.
  • the second electrode layer is patterned to form a plurality of electrodes within the layer.
  • an insulator is formed between the electrodes.
  • an insulator material may be conformally coated, sputter, vapor deposited or the like into and between the patterned electrodes of the second electrode layer. The insulator material is then etched back until only the insulator material between the patterned electrodes remains.
  • an insulator layer may be formed on the EAP layer.
  • the insulator layer may be formed by dip or spray coating or vapor deposition of an insulator onto the EAP layer.
  • the insulator layer is patterned to form inter-electrode insulator regions.
  • the insulator layer may be patterned utilizing one or more electrode masks.
  • a layer of a plurality of second electrodes is formed between the inter-electrode insulator regions.
  • the layer of the second electrodes may be formed by sputtering, platting or the like.
  • One or more electrode masks may also be used to control the deposition of the second electrode material to form a plurality of electrodes between the inter-electrode insulator regions.
  • the processes of forming EAP layers, layers of the first electrode and layers of the second electrodes may be repeated any number of times to form a plurality of EAP layers each disposed between a layer of a first electrode and a layer of second electrodes, wherein the patterning of plurality of the second electrodes in each respective layer are aligned with the patterning of the second electrodes in the other respective layers.
  • another EAP layer may be formed on the layer of the second electrodes.
  • the EAP layer may again be formed by dip or spray coating, sputtering, vapor deposition or the like.
  • Another layer of the first electrode may then be formed on the EAP layer.
  • the additional layer of the first electrode may again be formed by dip or spray coating, sputtering, platting, vapor deposition or the like of a conductive material.
  • the processes of forming additional EAP layers, additional layers of the first electrode and additional layers of the second electrodes may be repeated any number of times to form concentric active EAP regions.
  • the concentric active EAP regions are radial aligned with each other along the axis of the guide wire to forms radial stacks of active EAP regions.
  • the process may conclude with forming a sheath layer, lubricous layer, and/or the like, at 970.
  • the layer may be formed by dip or spray coating, sputtering, vapor deposition of the like of a polymer and/or lubricous material.
  • the lubricous material may be fluoropolymer, hydrophilic coating, urethane or other materials known to those experienced in the field.
  • the guide wire may include one or more EAP layers 210, one or more layers of a first electrode 220 and one or more layers of a second electrode 230.
  • the guide wire may also include one or more insulator layers 820, electrical interconnect layers, sheath layers, and the like.
  • the guide wire may further include additional layers (not shown) for forming strain gauges, temperature sensors, heating elements, cooling elements, variable or single frequency vibrating elements and/or the like.
  • the process may include forming a first layer of a first electrode on a first side of a first EAP layer, at 1 1 10.
  • the EAP layer is prepared and synthesized by polymerizing processes such as suspension, emulsion or solution methods.
  • the resulting polymer system should have a suitable molecular weight for application in the device.
  • the EAP material may, in one embodiment, be an electrostrictive relaxor ferroelectric EAP.
  • the electrostrictive relaxor ferroelectric EAP may be formed from a ferroelectric polymer by introducing chloride containing monomers such as chlorofluoroethylene (CFE) and chlorotrifluoroethylene (CTFE) or hexafluoropropylene to the copolymer.
  • CFE chlorofluoroethylene
  • CTFE chlorotrifluoroethylene
  • the electrostrictive relaxor ferroelectric EAP may be formed by irradiating a polyvinylidine fluoride polymer.
  • a patterned insulator layer may be formed on a second side of the EAP layer.
  • the insulator layer may be formed by vapor deposition of insulator onto the EAP layer.
  • the insulator layer is patterned utilizing one or more electrode mask layers.
  • a first layer of second electrodes is formed on the second side of the EAP layer between the patterned insulator layer.
  • the second electrode layer may be formed by sputtering, platting or the like a conductive material, such as gold, titanium, or aluminum, onto the EAP layer exposed by the patterned insulator layer.
  • a second EAP layer is formed on the first layer of second electrodes.
  • a second layer of the first electrode is formed on a side of the second EAP layer opposite the first layer of the second electrodes.
  • the processes of forming EAP layers, and alternating layers of the first electrode and layers of the second electrodes are repeated any number of times to form a plurality of EAP layers each disposed between a layer of a first electrode and a layer of second electrodes, wherein the patterning of plurality of the second electrodes in each respective layer are aligned with the patterning of the second electrodes in the other respective layers.
  • the EAP layers and layers of first elector and second electrodes may be manufacture in sheet form containing a plurality of individual guide wires. In such case the sheets may be cut to separate the plurality of individual guide wires.
  • the process may conclude with forming a sheath layer, lubricous layer, and/or the like.
  • the layer may be formed by dip or spray coating, sputtering, vapor deposition of the like of an insulator and/or lubricous material.
  • the lubricous material may be fluoropolymer, hydrophilic coating, urethaneor other materials known to those experienced in the field.
  • a sheet used to form the guide wire may include an EAP layer 210, a first electrode layer 220 and a layer of a plurality of second electrodes 230.
  • the plurality of second electrodes are arranged in a pattern such that when the sheet is rolled, folded or the like, corresponding second electrodes are aligned to form a stack of active EAP regions.
  • the sheet may be rolled, folded or the like about itself one or more times to form stacked of two or more active EAP regions.
  • a plurality of sheets may be rolled, folded or the like, together to form the guide wire.
  • the guide wire may further include one or more insulator layers, electrical interconnect layers, sheath layers, and the like.
  • the guide wire may further include additional layers (not shown) for forming strain gauges, temperature sensors, heating elements, cooling elements, variable or single frequency vibrating elements and/or the like.
  • the process may include forming a layer of a first electrode on a first side of an EAP layer, at 1310.
  • the EAP layer is prepared and synthesized by polymerizing processes such as suspension, emulsion or solution methods.
  • the resulting polymer system should have a suitable molecular weight for application in the device.
  • the EAP material may, in one embodiment, be an electrostrictive relaxor ferroelectric EAP.
  • the electrostrictive relaxor ferroelectric EAP may be formed from a ferroelectric polymer by introducing defects that shorten the crystallites of the polymer material.
  • a patterned insulator layer may be formed on a second side of the EAP layer.
  • the insulator layer may be formed by vapor deposition of insulator onto the EAP layer.
  • the insulator layer may then be patterned utilizing one or more electrode mask layers.
  • the mask layers may have a geometric pattern that expands in the direction that the sheet will be rolled, folded or the like.
  • a layer of second electrodes is formed on the second side of the EAP layer between the patterned insulator layer.
  • the layer of second electrodes may be formed by sputtering a conductive material, such as gold, aluminum or titanium, onto the EAP layer exposed by the patterned insulator layer.
  • the sheet of the EAP layer sandwiched between the layer of the first electrode and the layer of the second electrodes is then rolled, folded or the like such that respective active EAP portions are stacked on top of each other.
  • the process may conclude with forming a sheath layer, lubricous layer, and/or the like, at 1350.
  • the layer may be formed by dip or spray coating, sputtering, vapor deposition of the like of an insulator and/or lubricous material.
  • the lubricous material may be a fluoropolymer, hydrophilic coating, urethane or other materials known to those experienced in the field.
  • the sheet described in Figures 12 and 13 may be utilized to form a catheter by rolling or folding the sheet such that the sheet is formed about a lumen, duct, channel, tube, pipe or the like (hereinafter simply referred to as a catheter lumen). Furthermore, the plurality of second electrodes are arranged such that corresponding second electrodes are aligned to form a stack of active EAP regions about the catheter lumen.
  • the guide wire may include one or more EAP layers 210, one or more layers of a first electrode 220, one or more layers of a second electrode 230, one or more insulator layers 1410, 1420, one or more electrical interconnect layers 1430, sheath layers, and the like.
  • the guide wire may further include additional layers (not shown) for forming strain gauges, temperature sensors, heating elements, cooling elements, variable frequency vibration and/or the like.
  • the guide wire includes a first EAP layer disposed between a first electrode and a plurality of second electrodes.
  • the first electrode is coupled by one or more electrical interconnects (not shown) to a drive unit.
  • a first insulator layer may be disposed on the plurality of second electrodes.
  • Each of a plurality of interconnects is coupled to a respective one of the plurality of second electrodes through the first insulator layer.
  • a second insulator layer may be disposed over the first insulator layer and the plurality of interconnects to encapsulate the plurality of interconnects.
  • the interconnects each couple a respective one of the plurality of second electrodes to the drive unit.
  • the insulator regions may be formed by vapor deposition of an insulator material.
  • the insulator regions may in some cases be EAP when not disposed between a first and second electrode.
  • the plurality of interconnects may be formed by sputtering, platting and/or the like gold, titanium, aluminum and/or the like on the first insulator layer to form a conductive film, forming an interconnect mask and etching the conductive film exposed by the mask.
  • a catheter medical device in accordance with another embodiment of the present technology, is shown.
  • the catheter may include one or more layers of an EAP material 210, one or more layers of a first electrode 220 and one or more layers of a second electrode 230.
  • the one or more EAP layers are disposed between alternating ones of the first electrode and second electrode.
  • the catheter may further include one or more insulator layers, electrical interconnect layers, sheath layers, and the like.
  • the catheter may further include additional layers for forming strain gauges, temperature sensors, heating elements, cooling elements variable frequency vibration and/or the like.
  • a layer of a first electrode is formed on a first side of an EAP layer.
  • the EAP layer in one implementation, may be a sheet of electrostrictive relaxor ferroelectric EAP material.
  • a patterned insulator layer 820 may be formed on a second side of the EAP layer.
  • a layer of second electrodes is formed on the second side of the EAP layer between the patterned insulator layer. The second electrodes formed on the EAP exposed by the patterned insulator layer are therefore arranged in the given pattern.
  • Additional EAP layers, first electrode layers and second electrode layers may be formed such that each of a plurality of EAP layers are disposed between a layer of a first electrode and a layer of second electrodes, wherein the patterning of plurality of the second electrodes in each respective layer are aligned with the patterning of the second electrodes in the other respective layers.
  • the sheet of the one or more EAP layers sandwiched between the layers of the first electrode and the layers of the second electrodes is then bent so that opposite edges of the sheet meet. The opposite edges are coupled together to form a catheter lumen 1510 through the formed sheet.
  • a plurality of catheter may be formed from each sheet. In such case, the sheet is separate into a plurality of portions each used to form a catheter. Each portion may then be curled and the opposite edges coupled together to form the catheter.
  • the wire guide or catheter may include a catheter body 1610 and a plurality of EAP constructs 1620.
  • Each EAP construct may be a multi-layer EAP actuator.
  • the multi-layer EAP actuator may include one or more layers of an EAP material, one or more layers of a first electrode and one or more layers of a second electrode. The one or more EAP layers are disposed between alternating ones of the first electrode and second electrode.
  • each EAP construct may be molded into the wire guide or catheter body.
  • another EAP construct may be molded into the wire guide or catheter body.
  • each EAP construct may be inserted into pockets formed in the wire guide or catheter body.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un fil-guide orientable comprenant une ou plusieurs couches polymères électro-actives (EAP), chaque couche EAP étant disposée entre une couche d'une première électrode et une couche d'une pluralité de secondes électrodes.
PCT/US2014/010219 2013-01-04 2014-01-03 Dispositif à fil-guide médical orientable WO2014126653A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/734,866 US9370640B2 (en) 2007-09-12 2013-01-04 Steerable medical guide wire device
US13/734,866 2013-01-04

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WO2014126653A1 true WO2014126653A1 (fr) 2014-08-21

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